Olfaction DisordersNCT04799977
COVID-19: Post-covid Olfactory Disorders Assessment
An observational study of Olfaction Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Olfaction Disorders
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2020to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who presented with anosmia during their COVID19 infection (proven by a PCR+ test) and presenting at the ENT department consultation in university hospital more than 6 weeks after the end of symptoms,
Who may be able to join
- Adults patient,
- anosmia during a COVID19 acute infection (PCR+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared.
Who cannot join
- preexisting smell loss.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment
Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.
- Conditions
- Olfaction Disorders
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COVID19 infection with olfaction disorder | Patients, ≥18 ans, who suffered from an olfaction disorder while going through a COVID19 infection | |
| COVID19 infection without olfaction disorder | Patients, ≥18 ans, who suffered from a COVID19 infection without any olfaction disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sniffin Stick Tests (score TDI)
The subjective olfactory losses and recoveries are most often evaluated using the "Sniffin 'Sticks Test®", the current gold standard of objective olfactory tests allowing in a single examination to group together: the definition of an olfactory threshold, olfactory discrimination and olfactory identification in the form of an overall TDI score. Olfactory function using psychophysical tests before and after treatment or specific cares : Sniffin Stick Tests (score TDI). Results can classified patients in Anosmic (TDI<16,25), Hyposmic (16,25<TDI<30,75) and Normosmic (TDI>30,75). Higher score = better results. Minimal clinically important difference = 5,5.
Measured: 12 months : Evalation at the beginning and the end.
Secondary outcomes (13)
Hamilton Depression Rating Scale (HDRS)
The HDRS is used to assess the severity and progression of a patient's depressive state during a structured interview. This is a hetero-questionnaire consisting of 21 items completed in a few minutes by the examiner after an interview of at least 30 minutes. Before and after treatment or specific cares. Min-Max = 10-21. 10 < score < 13 = lights depression symptoms; 14<score<17 = mild deppression symptoms; >18 = severe deppression symptoms ; Interrelationships assessment between psychophysical tests and theses results
Measured: 12 months : Evaluation at the beginning and the end.
Situational anxiety and anxiety trait inventory (STAI-Y)
The STAI is a self-administered questionnaire comprising 40 items. This scale consists of 2 parts: one evaluating the anxiety-state (AE) which reflects the current emotional state and the other evaluating trait anxiety (AT) which reflects the usual emotional state. Before and after treatment or specific cares. Each score can vary from 20 to 80 with a "very high" (> 65), "high" (56-65), "average" (46-55), "low" (36-45) and "very low" (<or = 35). Interrelationships assessment between psychophysical tests and theses results
Measured: 12 months : Evaluation at the beginning and the end.
PTSD checklist for DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report that measures the 20 PTSD symptoms of DSM-5. The goals of PCL-5 are many, such as monitoring changes in symptoms during and after treatment, identifying individuals with PTSD, and making a provisional diagnosis of PTSD. Before and after treatment or specific cares. This self-rated scale scores each symptom from 0 to 4. Min-Max (better)=0-20. Interrelationships assessment between psychophysical tests and theses results.
Measured: 12 months : Evaluation at the beginning and the end.
GREMOTS
GREMOTS is a speech assessment test for neurological pathologies. This battery of tests takes into account the latest scientific development in the field and evaluates the different psycholinguistic variables of language. It also aims to detect disorders from the early stage of the disease. It componed of differents subtypes. We used the denomination and verification tasks. Semantic verification task: Min-Max=0-18. The cut-off score is between 5 and 25 percentil (inferior to 10-14). Denomination task: Min-Max=0-36. The cut-off score is between 5 and 25 percentil (inferior to 31-34).
Measured: 12 months : Evaluation at the beginning and the end.
PPT
The Pyramids and Palm Trees Test is a commonly used test of associative semanticknowledge comprising 52 items. In this test, participants are shown a stimulus (e.g., a pyramid) and asked to match it toeither of two images: A target (e.g., a palm tree) or a distracter (e.g., a fir tree). Subjects are required to use explicit semantic information of encyclopedic (e.g., pyramid: Palm tree vs. fir tree) or functional (e.g., wood: Saw vs. hammer) nature to select the correct match. Min-Max: 0-52. The 5% cut-off score corresponds to a Z-score of -1.65.
Measured: 12 months : Evaluation at the beginning and the end.
GROBER BUSCHKE
Grober and Buschke's is a commonly used test assesses verbal memory and is made up of 16 items belonging to 16 different semantic categories. The indexed reminder makes it possible to check the efficiency of the encoding and to dissociate memory disorders according to their type. Min-Max: 0-48. The cut-off score is inferior to 25 percentil.
Measured: 12 months : Evaluation at the beginning and the end.
TAP (Test of Attentional Performance)
The investigators used two tasks: the alertness task and the sustained attention task. In the alertness's task, reaction time is examined under two conditions. In the sustained attention task, a sequence of stimuli is presented on the monitor. The stimuli vary in a range of feature dimensions: colour, shape, size and filling. In order to adapt the difficulty of the task to the performance level of a subject, different levels of difficulty, that is, reactions to "shape" only or to "colour or shape", may be selected. Norms are betwaeen 19 and 89 for the alertness task and between 19 and 72 in sustained attention task.
Measured: 12 months : Evaluation at the beginning and the end.
TODA2 Olfactive Identification
The olfactory test was developed by the CoBTeK laboratory. It's an electronic test with mobile application which is componed of two tasks: a treshold task and an identification task. This task assess more precisely odor identification disorders by presenting semantic distractors at the higer treshold level. Min-Max treshold score: 1-4. Min-Max identification score: 0-24
Measured: 12 months : Evaluation at the beginning and the end.
Snaith-HAmilton Pleasure Scale (SHAPS)
The SHAPS is a 14-item self-administered questionnaire designed to assess a patient's hedonic capacity under different circumstances of daily life. Before and after treatment or specific cares. Min-Max = 0-14. Score >3 Anhédonic symptom; Interrelationships assessment between psychophysical tests and theses results
Measured: 12 months : Evaluation at the beginning and the end.
Inventory/Apathy Scale
The principle of the Apathy Inventory (IA) is to obtain information on the presence of apathy in patients with neurological disorders. The investigators used the clinical version of the Apathy Inventory. It assess the 4 clinical dimensions: - Emotional blunting - Lack of initiative - Lack of interest- Social interactions. Score for each dimension: 0= no problem; 2= moderate problem; 4= major problem. Min-Max total score= 0-16..
Measured: 12 months : Evaluation at the beginning and the end.
Olfactory Quality of life assessment - Short Version of questionnaire of olfactory disorders
Specific quality of life related to olfaction disorders concerning Social, eating, anxiety and daily annoyance related behaviors. Min-Max = 0-21, the higher is the score, the better is olfactory quality of life
Measured: 12 months : Evaluation at the beginning and the end.
General quality of life assessment (SF-36)
General quality of life score. Two scores related to an aggregated physical score and a mental score. Normatives values are near 50 for both. Less than 45 is worst subdomain quality of life, better than 55 is better subdomain quality of life. MCID = 5
Measured: 12 months : Evaluation at the beginning and the end.
The French quality of life and diet scale (QV-AF)
The QV-AF is a scale developed and validated in French to assess the quality of life in adults and in particular the relationship to diet. 4 subscales: diet / pleasure dimension, diet / relationship dimension, diet / psychology dimension, diet and physical condition dimension. Before and after treatment or specific cares. Min-Max (better)=0-400. Interrelationships assessment between psychophysical tests and theses results.
Measured: 12 months : Evaluation at the beginning and the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Oct 2020
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Olfaction DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799977
- Sponsor's protocol ID
- 21IUFCcovid01
- Status last verified
- Apr 2021
- First submitted
- 15 Feb 2021
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dumas LE, Vandersteen C, Metelkina-Fernandez V, Gros A, Auby P, Askenazy-Gittard F. Impact of post-COVID-19 olfactory disorders on quality of life, hedonic experiences and psychiatric dimensions in general population. BMC Psychiatry. 2024 Feb 8;24(1):111. doi: 10.1186/s12888-024-05538-0.
PubMed 38331799
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Olfactory Loss After COVID-19 : Olfactive Disorder, Psychiatric and/or Cognitive Assessments With and Without a Treatment
- ClinicalTrials.gov ID
- NCT04799977
- Acronym / sponsor ID
- 21IUFCcovid01
- Conditions
- Olfaction Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Covid 19 cause an olfactory loss in more than 80% of cases. This loss most often regresses but leaves 20% of patients with an olfactory complaint, particularly with regard to the quality of daily life. The neuro-cognitive implications involved with COVID19 and the consequences of persistent olfactory loss remain unknown. The effectiveness of therapeutic management, in particular olfactory re-education, has not yet been clarified. Objectives are the assessment of patients olfactory disorders, psychiatrics and neurocognitives specificities after a COVID, before and after treatment or specific cares.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19 infection with olfaction disorder | – | –Patients, ≥18 ans, who suffered from an olfaction disorder while going through a COVID19 infection |
| COVID19 infection without olfaction disorder | – | –Patients, ≥18 ans, who suffered from a COVID19 infection without any olfaction disorders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who presented with anosmia during their COVID19 infection (proven by a PCR+ test) and presenting at the ENT department consultation in university hospital more than 6 weeks after the end of symptoms,
Key inclusion criteria (2 listed)
- Adults patient,
- anosmia during a COVID19 acute infection (PCR+) and persistant olfactive disoders at least 6 weeks after symptoms disappeared.
Key exclusion criteria (1 listed)
- preexisting smell loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sniffin Stick Tests (score TDI)
Time frame: 12 months : Evalation at the beginning and the end.
The subjective olfactory losses and recoveries are most often evaluated using the "Sniffin 'Sticks Test®", the current gold standard of objective olfactory tests allowing in a single examination to group together: the definition of an olfactory threshold, olfactory discrimination and olfactory identification in the form of an overall TDI score. Olfactory function using psychophysical tests before and after treatment or specific cares : Sniffin Stick Tests (score TDI). Results can classified patients in Anosmic (TDI<16,25), Hyposmic (16,25<TDI<30,75) and Normosmic (TDI>30,75). Higher score = better results. Minimal clinically important difference = 5,5.
13 secondary outcomes
Hamilton Depression Rating Scale (HDRS)
Time frame: 12 months : Evaluation at the beginning and the end.
Situational anxiety and anxiety trait inventory (STAI-Y)
Time frame: 12 months : Evaluation at the beginning and the end.
PTSD checklist for DSM-5 (PCL-5)
Time frame: 12 months : Evaluation at the beginning and the end.
GREMOTS
Time frame: 12 months : Evaluation at the beginning and the end.
PPT
Time frame: 12 months : Evaluation at the beginning and the end.
GROBER BUSCHKE
Time frame: 12 months : Evaluation at the beginning and the end.
TAP (Test of Attentional Performance)
Time frame: 12 months : Evaluation at the beginning and the end.
TODA2 Olfactive Identification
Time frame: 12 months : Evaluation at the beginning and the end.
Snaith-HAmilton Pleasure Scale (SHAPS)
Time frame: 12 months : Evaluation at the beginning and the end.
Inventory/Apathy Scale
Time frame: 12 months : Evaluation at the beginning and the end.
Olfactory Quality of life assessment - Short Version of questionnaire of olfactory disorders
Time frame: 12 months : Evaluation at the beginning and the end.
General quality of life assessment (SF-36)
Time frame: 12 months : Evaluation at the beginning and the end.
The French quality of life and diet scale (QV-AF)
Time frame: 12 months : Evaluation at the beginning and the end.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 38331799Dumas LE, Vandersteen C, Metelkina-Fernandez V, Gros A, Auby P, Askenazy-Gittard F. Impact of post-COVID-19 olfactory disorders on quality of life, hedonic experiences and psychiatric dimensions in general population. BMC Psychiatry. 2024 Feb 8;24(1):111. doi: 10.1186/s12888-024-05538-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfaction Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sniffin Stick Tests (score TDI) (time frame: 12 months : Evalation at the beginning and the end.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04799977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.